Shots:

• The sBLA was based on the P-III trial evaluating the efficacy & safety of Dupixent added to TCS as an add-on maintenance treatment vs TCS alone in children aged 6mos. to 5yrs. with mod. to sev. AD whose disease is not adequately controlled with topical prescription therapies
• The trial met all 1EPs & 2EPs i.e., the therapy showed an improvement in skin clearance and reduced overall disease severity and itch @16wks. The results were consistent with the safety profile of Dupixent for patients aged ≥6yrs.
• The US FDA’s decision is expected on June 9, 2022. Dupixent is approved in the EU, Japan & other countries globally for use in specific patients with AD and asthma or CRSwNP

Ref: Regeneron | Image: The Print